The following data is part of a premarket notification filed by Osteomed Corp. with the FDA for Osteomed Ib Drill.
Device ID | K911937 |
510k Number | K911937 |
Device Name: | OSTEOMED IB DRILL |
Classification | Handpiece, Air-powered, Dental |
Applicant | OSTEOMED CORP. 6062 SAN FERNANDO RD. Glendale, CA 91202 |
Contact | Rich A Buss |
Correspondent | Rich A Buss OSTEOMED CORP. 6062 SAN FERNANDO RD. Glendale, CA 91202 |
Product Code | EFB |
CFR Regulation Number | 872.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-05-01 |
Decision Date | 1991-06-10 |